FDA approval of generic version of cancer drug Doxil is expected
to help resolve shortage. FDA has approved its first generic version of the
cancer drug Doxil (doxorubicin hydrochloride liposome
injection). Doxil is currently on the FDA’s drug shortage list. For products on
the shortage list, the FDA’s Office of Generic Drugs is using a priority review
system to expedite the review of generic applications to help alleviate
shortages.
The agency is committed to
doing everything we can to address drug shortages so that patients can get the
medicines they need when they need them. During the past year, FDA has been
working to ensure that supplies of doxorubicin HCl liposome injection were not
interrupted. Generic drugs approved by the FDA have the same high quality and
strength as brand-name drugs. The generic manufacturing and packaging sites pass
the same quality standards as those of brand-name drugs.
Manufacturer of Doxil :
Sun Pharma Global FZE (Sun)
Mode of Administration of the drug: Doxil injection is
administered intravenously by a health care professional.
Concentration: 20 milligram and 50 milligram vials.
In order to compensate the
shortage of Doxil injection, FDA announced that it would exercise enforcement
discretion for temporary controlled importation of Lipodox, an alternative of
Doxil produced both by Sun and Caraco Pharmaceutical Laboratories Ltd, which is
not approved in USA. Enforcement discretion was also used to release one lot of
Janssen’s Doxil made under an unapproved manufacturing process.
For the present time, FDA intends to continue
exercising enforcement discretion for importation of Lipodox, and limited
supplies of Doxil are available. Once supplies of Sun’s generic doxorubicin
hydrochloride liposome injection are sufficient to meet projected demand, FDA
expects to stop exercising enforcement discretion for any unapproved
doxorubicin HCl liposomal product.Reference:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm337872.htm
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